正Clinical Research Scientist

Clinical Research Scientist

Clinical Research Scientist

募集要項

Reporting to the Head of Clinical Research Japan, the Clinical Research Scientist (CRS) plays an integral role in the scientific planning, execution and reporting of Japanese clinical studies for development compounds.
Although generally assigned to a specific therapeutic area, the CRS may support local clinical research activities across development programs. The overall responsibilities of the CRS include the following:
・Acts as the local scientific expert for assigned clinical research activities, addressing questions from internal functions and external Japanese physicians and research scientists.
・Provides scientific support to functions including but not limited to GSI Clinical Research, Clinical Operations, Biostatistics, Data Management, Medical Writing and Medical Affairs.
Provides guidance to ensure scientific and clinical issues are addressed in a consistent manner
・Responsible for identifying, establishing and maintaining science-based relationships with Japanese therapeutic area experts to support development programs.
・Responsible for the design of Japanese clinical research studies including authoring of study concepts and protocol synopses. Works with the Clinical Operations team for the development, finalization and amendment (as applicable) of study protocols
・Prepares and presents (if applicable) scientific information concerning development programs internally and at external meetings as required.
Responsible for drafting regulatory Briefing Documents and slide presentations for use at
・PMDA and MHLW meetings. Attends and presents position at informal and official Consultation meetings with PMDA and MHLW
・Working with Regulatory Affairs and the respective GSI Project Team, prepares written responses to PMDA, MHLW and IRB queries.

募集条件

・MS degree or above.
・Minimum of 5 years of experience within clinical research in the pharmaceutical industry.
Experience in cardiovascular area is preferable (not mandatory).
・Experience in preparation for and attendance at PMDA/MHLW consultation meetings.
・Direct experience in the preparation and filing of CTNs, J-NDAs and other clinical research
documentation.
・Current, working knowledge of ICH and local guidelines and PMDA/MHLW notifications.
・Good communication and discussion skills to build and maintain working relationships with
Japanese physician and research scientists.
・Strong organizational skills and ability to manage multiple projects simultaneously.
・Fluency in oral and written English.

正Medical Scientist

Medical Scientist

募集要項

・Responds to clinical inquiries regarding marketed or developmental products.
・Presents scientific and clinical data for these products.
・Identifies and develops regional and national opinion leaders to support products and trains approved speakers through personal contacts and on-site visits.
・Establishes strong relationships with opinion leaders, clinical investigators and providers at academic and non-academic settings.
・Assists with sales force training at national and regional levels.
・Assists with Phase IV program that includes collaboration with investigators and internal personnel.
・Assists with site selection for both Phase IV and other clinical trials.
・Anticipates obstacles and difficulties that may arise in the field and resolves them in a collaborative manner.
・Works collaboratively with personnel in Sales, Marketing, Clinical Research, Global Safety and Medical Communication.
・Sought for advice and collaboration within and outside.

・Utilizes scientific resources to deliver impactful presentations in a variety of different settings.
・Travels to appointments, meetings and conferences on a frequent and regular basis, occasionally with short notice.
・Must be fully cognizant of all relevant scientific data and regulatory requirements for field-based personnel.
・Must be committed to continuing education to maintain knowledge base.
・Must have the ability to work as a member of several teams that may overlap such as national MS team, regional sales team, national accounts, and others.
・Utilizes scientific resources for impactful presentations in a variety of different settings.

募集条件

・Advanced degree (i.e. MD, DO, PharmD, PhD, Nurse Practitioner or Physician Assistant) preferred or may have a BS in pharmacy or BS/MS nursing with extensive clinical and/or industry experience.
・Relevant experience must include at least 3 yrs clinical practice experience in hepatology, viral hepatitis, HIV or infectious diseases.
・Pharmaceutical industry experience desirable.
・Excellent verbal, written, and interpersonal communication skills are required in both Japanese and English.
・Experience in preparing and delivering presentations is required.
・Experience in the management or investigation of clinical trials is highly desirable.
・Clinical patient contact experience is highly desirable.

正Drug Safety, Associate Director / Senior Manager

Create strategy to manage safety information in Japan and outside Japan in
close collaboration with the drug safety

Drug Safety, Associate Director / Senior Manager

募集要項

・In close communication and collaboration with the headquarters, the drug safety
director / associate director / senior manager has a full responsibility of case
management and safety reporting as well as planning and managing post-marketing
safety surveillance. Primary responsibilities are as follow:
・Create strategy to manage safety information in Japan and outside Japan in
close collaboration with the drug safety.
・Oversee the tasks of CROs for safety case management and solve any
problems ensuring to meet timelines and milestones.
・Lead the preparation of any safety reporting.
・Ensure the safety reporting to PMDA in a timely manner.
・Plan and manage the risk management plan for J-NDA.
・Negotiate with the PMDA on the language on safety in the Japanese label.
・Oversee the execution of the post-marketing surveillance.
・Directs development of SOPs within department.

募集条件

・Experiences in drug safety/PMS in at least 10 years.
・Experiences in selection and oversight of CROs and vendors.
・Experiences in case management and preparations of safety reports.
・Experiences in PMS planning and execution.
・Strong familiarity with ICH/local guidelines and PMDA/MHLW notifications.
・Good skills of communication in Japanese and English (>730 TOEIC)
・Must have demonstrated organizational skills to manage multiple projects
simultaneously.

・Experiences in liver disease or oncology area are preferred.
・Registered Pharmacist is preferred.